CORPORATEINTEGRITYAGREEMENT BETWEENTHE OFFICE OF INSPECTOR
GENERAL
OFTHEDEPARTMENTOFHEALTHANDHUMANSERVICESANDMEDTRONICSOFAMORDANEKUSA,INC.I.PREAMLE
MedtronicSofamorDanekUSA,Inc.(MSD)andMedtronic,Inc.(Medtronic)enteredintoaSettlementAgreementwiththeUnitedStatesandthisCorporateIntegrtyAgreement(CIA)isincorporatedbyreferenceintotheSettlementAgreement.MSDisawhollyownedsubsidiaryofMedtronic.MSDherebyentersintothisCIAwiththeOffceofInspectorGeneral(OIG)of
theUnitedStatesDepartentof
HealthandHumanServices(HHS)andMedtronicherebyentersintocertainspecifiedprovisionsofthisCIAtopromotecompliancebyitsofficers,directors,employees,contractors,andagentswiththestatutes,regulations,andwrittendirectivesofMedicare,Medicaid,andallotherFederalhealthcareprograms(asdefinedin42D.S.C.1320a-7b(f))(Federalhealthcareprogramrequirements).ThisCIAshallapplyonlytoU.S.operationsofMSDandMedtronicthataresubjecttoU.S.Federalhealthcareprogramrequirements.MedtronicistheparentcorporationofMSD.MedtronicrepresentedtotheOIGthat,priortotheeffectivedateofthisCIA,Medtronicestablishedavoluntarycomplianceprogram,whichincludesacorporatecomplianceofficer,acorporatecompliancecommittee,aCodeofEthicsandBusinessConductforallemployees,writtenpoliciesandprocedures,educationalandtraininginitiatives,reviewanddisciplinaryprocedures,aconfidentialdisclosureprogram,anineligiblepersonsscreeningprogram,andinternalauditandreviewprocedures.MedtronicagreestocontinuetheoperationofitscompliancemeasuresinaccordancewiththetermssetforthbelowforthetermofthisCIA.MedtronicwillensurethatduringthetermofthisCIA,itshallcomplywithcertainintegrtyobligationsenumeratedinthisCIA.II.TERMANDSCOPEOFTHECIA
A.TheperiodofthecomplianceobligationsassumedbyMedtronicandMSDunderthisCIAshallbe5yearsfromtheeffectivedateofthisCIA,unlessotherwisespecified.TheeffectivedateshallbethedatethatMedtronicorMSDbecomesobligatedtomakepaymenttotheUnitedStatesoftheSettlementAmountfromtheEscrowAccountestablishedpursuanttotheSettlementAgreementbetweentheUnitedStates,Medtronic,andMSD,signedonoraboutthedateofsignatureofthisCIA(EffectiveDate).Eachone-yearperiod,beginningwiththeone-yearperiodfollowingtheEffectiveDate,shallbereferredtoasa"ReportingPeriod."B.SectionsVII,VIII,IX,X,andXIshallexpirenolaterthan120daysafterOIG'sreceiptof:(1)MedtronicandMSD'sfinalannualreport;or(2)anyadditionalmaterialssubmittedbyMedtronicorMSDpursuanttoOIG'srequest,whicheverislater.C.ThescopeofthisCIAshallbegovernedbythefollowingdefinitions:1."Arrangements"shallmeaneveryarrangementortransactionenteredintobyMSDthat(a)involves,directlyorindirectly,theoffer,payment,solicitation,orreceiptofanythingofvalue;and(b)isbetweenMSDandanyactualorpotentialsourceofhealthcarebusinessorreferralsofhealthcarebusinesstoMSDoranyactualorpotentialrecipientofhealthcarebusinessorreferralfromMSD.Theterm"source"shallincludeanyphysician,contractor,vendor,oragent;andtheterm"healthcarebusinessorreferrals"shallbereadtoincludereferrng,recommending,orarrangingfor,ordering,leasingorpurchasingofanygood,facilty,item,orserviceforwhichpaymentmaybemadeinwholeorinpartbyaFederalhealthcareprogram.a."ContractualArrangements"shallmeaneveryArrangementthat
iscontractualinnatureandshallincludeallArrangementsrelatedtotheprovisionofservicestoMSD,includingbutnotlimitedto,training,education,consulting,research,clinicalstudies,focusgroups,physicianadvisoryboardsaswellasintellectualpropert,grants,andcharitablecontrbutions.CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 2
b."Non-ContractualArrangements"shallmeanallArrangements that are
not Contractual Arangements.
2."CoveredPersons"includes:a.allofficers,directorsandemployeesofMedtronicandMSD,includingbutnotlimitedto,Medtronic'sCEOandMSD'sPresidentandallmembersofMedtronic'sandMSD'srespectivemanagementinclusiveofseniorvicepresidents,vicepresidents,directors,andmanagers;b.allcontractors,subcontractors,agents,andotherpersonswho,onbehalfofMSD,performfunctionsrelatedtothesaleormarketingofitemsorsrvicesreimbursablebyFederalhealthcareprograms;andc.allindividualsthatsellormarketonbehalfof
MedtronicitemsorservicesforwhichreimbursementmaybemadebytheFederalhealthcareprograms.Notwithstandingtheabove,thistermdoesnotincludepart-timeorperdiememployees,contractors,subcontractors,agents,andotherpersonswhoarenotreasonablyexpectedtoworkmorethan160hoursperyear,exceptthatanysuchindividualsshallbecome"CoveredPersons"atthepointwhentheyworkmorethan160hoursduringthecalendaryear.3."RelevantCoveredPersons"includespersonsinvolvedinthedevelopment,approval,management,implementation,use,orreviewofanyofMSD'sArrangements.III.CORPORATEINTEGRITYOBUGAnONS
A.ComplianceOffcersandCommittees. 1.ComplianceOffcers.a. Medtronic
represented to the OIG that, prior to the Effective
CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
3DateofthisCIA,MedtronicappointedaComplianceOfficerwhoisresponsiblefordevelopingandimplementingpolicies,procedures,andpracticesdesignedtoensurecompliancewithFederalhealthcareprogramrequirements.Totheextentnotalreadyaccomplished,within120daysaftertheEffectiveDate,theMedtronicComplianceOfficershallberesponsiblefordevelopingandimplementingpolicies,procedures,andpracticesdesignedtoensurecompliancewiththerequirementssetforthinthisCIA.Totheextentnotalreadyaccomplished,within120daysaftertheEffectiveDate,theMedtronicComplianceOfficershallbeamemberofMedtronic'sseniormanagement..TheMedtronicComplianceOfficershallmakeperiodic(atleastquarterly)reportsregardingcompliancemattersdirectlytoMedtronic'sComplianceCommitteeandChiefExecutiveOfficerandshallhavedirectaccesstoMedtronic'sBoardofDirectors.
The Medtronic Compliance Officer shall report
directlytoMedtronic'sChiefExecutiveOfficerregardingcompliance
matters. The Medtronic Compliance Officer shall
notbeorbesubordinatetoMedtronic'sGeneralCounselorChiefFinancialOfficer.TheMedtronicComplianceOfficershallberesponsibleformonitoringtheday-to-daycomplianceactivitiesengagedinbyMedtronicaswellasforanyreportingobligationsimposeduponMedtronicunderthisCIA.TheCompliance
Officer function outlined in this Section III.A.1
shallcontinueduringtheTermofthis CIA.
b.MSDrepresentedtotheOiGthat,priortotheEffectiveDateofthisCIA,MSDappointedaComplianceOfficerwhoisresponsiblefordevelopingandimplementingpolicies,procedures,andpracticesdesignedtoensurecompliancewithFederalhealthcareprogramrequirements.Totheextentnotalreadyaccomplished,within120daysaftertheEffectiveDate,theMSDComplianceOfficershallberesponsiblefordevelopingandimplementingpolicies,procedures,andpracticesdesignedtoensurecompliancewiththerequirementssetforthinthisCIA.Totheextentnotalreadyaccomplished,within120CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 4
.daysaftertheEffectiveDate,theMSDComplianceOfficershallbeamemberofMSD'sseniormanagement.TheMSDComplianceOfficershallmakeperiodic(atleastquarterly)reportsregardingcompliancemattersdirectlytoMSD'sComplianceCommitteeandPresidentandshallhavedirectaccesstoMedtronic'sandMSD'sBoardsofDirectors.TheMSDComplianceOfficershallreportdirectlytoMSD'sPresidentregardingcompliancematters.TheMSDComplianceOfficershallnotbeorbesubordinatetoMedtronicorMSD'sGeneralCounselorChiefFinancialOfficer.TheMSDComplianceOffcershallberesponsibleformonitoringtheday-to-daycomplianceactivitiesengagedinbyMSDaswellasforanyreportingobligationscreatedunderthisCIA.TheComplianceOfficerfunctionoutlinedinthisSectionIILA.lshallcontinueduringtheTermofthisCIA.MedtronicandMSDshallreporttoOIG,inwriting,anychangesintheidentityorpositiondescriptionoftheComplianceOfficers,oranyactionsorchangesthatwouldaffecttheComplianceOfficers'abilitytoperformthedutiesnecessarytomeettheobligationsinthisCIA,within15daysaftersuchachange.2.ComplianceCommittees.
a. Medtronic represented to the OIG that, prior to the Effective
Date of
thisCIA,MedtronicappointedaComplianceCommittee.TheComplianceCommitteeincludesandshallcontinuetoincludetheComplianceOfficerandmembersofseniormanagementresponsibleforfinance,clinical,humanresources,legal,sales,andoperations.TheComplianceCommitteeshallsupporttheComplianceOfficerinfulfillinghisorherresponsibilities(e.g.,assistintheanalysisofMedtronic'sriskareasandoverseemonitoringofinternalandexternalaudits
and investigations). The Compliance Committee function
outlinedinthisSectionIII.A.2shallcontinueduringtheTermofthisCIA.b.MSDrepresentedtotheOIGthat,priortotheEffectiveDateofthisCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
5CIA,MSDappointedaComplianceCommittee.TheComplianceCommitteeincludesandshallcontinuetoincludetheComplianceOfficerandmembersofseniormanagementresponsibleforfinance,clinical,humanresources,legal,sales,andoperations.TheComplianceCommitteeshallsupporttheComplianceOfficerinfulfillinghisorherresponsibilities(e.g.,assistintheanalysisofMSD'sriskareasandoverseemonitoringof
internalandexternalauditsandinvestigations).TheComplianceCommitteefunctionoutlinedinthisSectionIII.A.2shallcontinueduringtheTermofthisCIA.MedtronicandMSDshallr~porttoOIG,inwriting,anychangesinthecompositionoftheComplianceCommittees,oranyactionsorchangesthatwouldaffecttheComplianceCommittees'abilitytoperformthedutiesnecessarytomeettheobligationsinthisCIA,within15daysaftersuchachange.B.WrittenStandards.
1.CodeofConduct.MedtronicrepresentedtotheOIGthat,priortotheEffectiveDateofthisCIA,MedtronicdevelopedaCodeofConduct("theCodeofConduct"),whichisapplicabletoMSD.MedtronicandMSDshallmakethepromotionof,andadherenceto,theCodeofConductanelementinevaluatingthe
performance of all employees. The Code of Conduct shall, at a
minimum, set
forth:a.Medtronic'scommitmenttofullcompliancewithallfederal,stateandlocallawsandregulations(whichincludesFederalhealthcareprogramrequirements);b.Medtronic'srequirementthatallCoveredPersonsshallbeexpectedtocomplywithallFederalhealthcareprogramrequirementsandwithMedtronic'sownPoliciesandProceduresasimplementedpursuanttothisSectionIII.B(includingtherequirementsofthisCIA);c.therequirementthatallCoveredPersonsshallbeexpectedtoreporttotheirComplianceOfficer,orotherappropriateindividualsdesignatedbyCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 6
MedtronicorMSD,suspectedviolationsofanyFederalhealthcareprogramrequirementsorofMedtronic'sandMSD'sownPoliciesandProcedures;d.thepossibleconsequencestoMedtronic,MSD,andMedtronic'sandMSD'sCoveredPersonsoffailuretocomplywithallFederalhealthcareprogramrequirementsandwithMedtronicanditssubsidiaries'PoliciesandProceduresandthefailuretoreportsuchnon-compliance;ande.therightofallindividualstousetheDisclosureProgramdescribedinSectionIII.F,andMedtronic'sandMSD'scommitmenttononretaliationandtomaintain,asappropriate,confidentialityandanonymitywithrespect
to such disclosures.
Totheextentnotalreadyaccomplished,within15daysaftertheEffectiveDate,MedtronicandMSDshalldistrbutetheCodeofConducttoeachCoveredPersonandeachCoveredPersonwilcertify,inwritingorelectronically,thatheorshehasreceived,read,understoodandshallabidebyMedtronic'sCodeofConduct.MedtronicandMSDmaydistrbutetheCodeofConductandtherequiredcertificationtoeachCoveredPersoneitherelectronicallyorinhard-copyform.NewCoveredPersonsshallreceivetheCodeofConductandshallcompletetherequiredcertificationwithin30daysafterbecomingaCoveredPersonorwithin120daysaftertheEffectiveDate,whicheverislater.MedtronicshallperiodicallyreviewtheCodeofConducttodetermineifrevisionsareappropriateandshallmakeanynecessaryrevisionsbasedonsuchreview.AnyrevisedCodeofConductshallbedistrbutedwithin60daysafteranyrevisionsarefinalized.EachCoveredPersonshallcertify,inwrtingorelectronically,thatheorshehasreceived,read,understood,andshallabidebytherevisedCodeofConductwithin30daysafterthedistrbutionoftherevisedCodeofConduct.2.
Policies and Procedures. Within 120 days after the Effective Date,
MedtronicandMSDshallimplementwrittenPoliciesandProceduresregardingtheoperationofMedtronic'sandMSD'scomplianceprogramsandtheircompliancewithFederalhealthcareprogramrequirements.Ataminimum,thePoliciesandProceduresshalladdress:CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 7a. the subjects relating
to the Code of Conduct identified in Section IILB.1;b. the
expectation that all Covered Persons shall comply with the
CodeofConduct,thePoliciesandProceduresrequiredunderthisSection,andthisCIA;c.
42 U.S.c. 1320a-7b(b) (Anti-Kickback Statute) and the
regulationsandotherguidancedocumentsrelatedtothisstatute,andbusinessorfinancialarrangementsorcontractsthatmayviolatetheAnti-KickbackStatute,andtheapplicabilityoftheAnti-KickbackStatutetoArrangementsasthattermisdefinedinSectionn.c.1;andd.forMSDonly,therequirementssetforthinSectionIII.D(CompliancewiththeAnti-KickbackStatute),includingbutnotlimitedtotheArrangementsDatabase,theinternalreviewandapprovalprocess,andthetrackingofremunerationtoandfromsourcesofhealthcarebusinessorreferrals.Within120daysaftertheEffectiveDate,therelevantportionsof
thePoliciesandProcedures shall be distrbuted to all individuals
whose job functions relate to those Policies and Procedures.
Distrbution may include publishing such Policies and
ProceduresonMedtronicandMSD'sintranetorotherinternalwebsitesavailabletoallemployees.IfeitherMedtronicorMSDusessuchanelectronicmethodofdistrbution,itmustnotifytheindividualsreceivingthePoliciesandProceduresthatthePoliciesandProcedureswilbedistrbutedinsuchamanner,anditmustadopttrackingprocedures
designedtotrackthedistrbutionandreasonablyensurethatallappropriateindividualsreceived
the Policies and Procedures. Appropriate and knowledgeable staff
shall be
availabletoexplainthePoliciesandProcedures.AtleastonceperMedtronicandMSD'sfiscalyear(andmorefrequently,ifappropriate),MedtronicandMSDshallassessandupdateasnecessarythePoliciesandProcedures.Within30daysaftertheeffectivedateofanyrevisions,therelevantportionsofanysuchrevisedPoliciesandProceduresshallbedistrbutedtoallindividualswhosejobfunctionsrelatetothosePoliciesandProcedures.CorporateIntegrtyAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 8C.TrainingandEducation.
1.GeneralTraining.Within120daysaftertheEffectiveDate,MedtronicandMSDshallprovideatleastonehourofGeneralTrainingtoeachCoveredPerson.This
training, at a minimum, shall explain Medtronic's and MSD's:
a.CIArequirements;and b.ComplianceProgram(includingtheCodeof
ConductandthePoliciesandProceduresastheypertaintogeneralcomplianceissues).NewCoveredPersonsshallreceivetheGeneralTrainingdescribedabovewithin30daysafterbecomingaCoveredPersonorwithin120daysaftertheEffectiveDate,whicheverislater.AfterreceivingtheinitialGeneralTrainingdescribedabove,eachCoveredPersonshallreceiveatleastonehourofGeneralTrainingperMedtronic'sandMSD'sfiscalyear.2.Anti-KickbackTraining.Within120daysaftertheEffectiveDate,eachRelevantCoveredPersonshallreceiveatleastthreehoursofAnti-KickbackTraining,inadditiontotheGeneralTrainingrequiredabove.TheAnti-KickbackTrainingshallinclude
a discussion of:
a.ArrangementsthatpotentiallyimplicatetheAnti-KickbackStatute,aswellastheregulationsandotherguidancedocumentsrelatedtothisstatute;b.Medtronic'sandMSD'spolicies,procedures,andotherrequirementsrelatingtoArrangements,includingbutnotlimitedtotheArrangementsDatabase,theinternalreviewandapprovalprocess,andthetrackingofremunerationtoandfromsourcesofhealthcarebusinessorreferralsrequiredbySectionIII.Dof
theCIA;c.thepersonalobligationofeachindividualinvolvedinthe
development,approval,management,implementation,use,orreviewofMSD'sArrangementstoknowtheapplicablelegalrequirementsCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
9andMedtronic'sandMSD'spoliciesandprocedures;d.thelegalsanctionsundertheAnti-KickbackStatute;ande.examplesof
violationsoftheAnti-KickbackStatute.NewRelevantCoveredPersonsshallreceivethistrainingwithin30daysafterthebeginningoftheiremploymentorbecomingRelevantCoveredPersons,orwithin120daysaftertheEffectiveDate,whicheverislater.AnMSDemployeewhohascompletedtheAnti-KickbackTrainingshallreviewanewRelevantCoveredPerson'sworkuntilsuchtimeasthenewRelevantCoveredPersoncompleteshisorherAnti-KickbackTraining.AfterreceivingtheinitialAnti-KickbackTrainingdescribedinthisSection,eachRelevantCoveredPersonshallreceiveatleasttwohoursofAnti-KickbackTrainingperfiscalyearofMSD.3.Certifcation.EachindividualwhoisrequiredtoattendtrainingpursuanttothisSectionIII.Cshall,uponcompletionofthetraining,certify,inwritingorinelectronicform,thatheorshehasreceivedtherequiredtraining.Thecertificationshallspecifythetyeoftrainingreceivedandthedatereceived.TheComplianceOfficers(ordesignees)shallretainthecertifications,alongwithallcoursematerials.TheseshallbemadeavailabletoOIG,uponrequest.4.QualifcationsofTrainer.PersonsprovidingthetrainingrequiredbythisSectionIII.Cshallbeknowledgeableaboutthesubjectarea.5.UpdateofTraining.Atleastoncepertheirfiscalyear,MedtronicandMSDshallreviewthetrainirtgprogramsdevelopedtosatisfytherequirementsofthisSectionIII.C,and,whereappropriate,updatethetrainingtoreflectchangesinFederalhealth
care program requirements, any issues discovered during internal
audits, the
ArrangementsReview,andanyotherrelevantinformation.6.TrainingMethods.MedtronicandMSDmayprovidethetrainingrequiredunderthisCIAthroughvideotape,DVD,appropriatecomputer-basedtrainingapproaches,orothercomparablemethodsnotinvolvingin-persontraining.IfMedtronicCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
10andMSDchoosetoprovidetrainingpursuanttoanysuchmethod,theyshallalsomakeavailableatreasonabletimesappropriatelyqualifiedandknowledgeablestaffortrainerstoanswerquestionsorprovideadditionalinformationtotheindividualsreceivingsuchtraining.7.IndependentDistributors.WhereaCoveredPersonorRelevant
CoveredPersonisanindependentdistrbutor,theGeneralTrainingobligationsunderthisCIAshallbemetsolongasthetrainingisprovidedtoamemberofmanagementoftheindependentdistrbutor.MSDshallrequest,andwithrespecttoallnewArrangements,requiretheindependentdistrbutortotakereasonablestepstoappriseitsemployeesandotherpersonnelregardingthecontentofthetraining.Inaddition,MSDshallrequiresuchentitiestodothefollowing:a.
agree to abide by the Code of Conduct or adopt its own Code of
ConductaddressingsubstantiallyalloftherequirementsofSectionIII.B.1;b.distrbutethefollowingmaterialstoitsemployeesandsubcontractorsworkingonMSDmatters:(1)Medtronic'soritsownCodeofConduct;(2)copiesofrelevantMSDpoliciesandproceduresrelatingtotheworkoftheindependentdistrbutor;and(3)informationaboutMSD'sDisclosureProgram(includingthehotlinenumber);c.
provide either directly or through MSD, Anti-Kickback Training
(asdescribedinSectionIILC.2)toitsemployeesandsubcontractorstotheextenttheyareinvolvedwiththedevelopment,approval,management,implementation,use,orreviewofanyofMSD'sArrangements;d.certifytoMSDthatallemployeesandsubcontractorsworkingonMSDmattershave:(1)beenscreenedtoexcludeIneligiblePersonsinaccordancewiththerequirementsof
SectionIII.GoftheCIA;(2)receivedacopyofMedtronic'sCodeofConductoritsownCodeofConduct,informationaboutMSD'sDisclosureProgram(includingthehotlinenumber);and(3)totheextentapplicable,receivedAnti-Kickbacktraining.CorporateIntegrityAgreementbetween.
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
11D.CompliancewiththeAnti-KickbackStatute.1. Arrangements
Procedures. Within 120 days after the Effective Date, MSD
shallcreateproceduresreasonablydesignedtoensurethateachexistingandneworrenewedArangement,includingContractualArrangementsandNon-ContractualArangements,
does not violate the Anti-Kickback Statute (taking into account the
regulations,directives,andguidancerelatedtothisstatute)(ArrangementsProcedures).Theseproceduresshallincludethefollowing:a.
creating and maintaining a database of all existing and new or
renewedArrangements,includingContractualArrangementsandNon-ContractualArrangements,thatshallcontaintheinformationspecifiedinAppendixA(ArrangementsDatabase);b.
tracking remuneration to and from MSD to all other parties to
Arrangements;c.trackingserviceandactivitylogstoensurethatpartiestotheArrangement(s)areperformingtheservicesrequiredundertheapplicableArrangement(s)(ifapplicable);d.monitoringtheuseofleasedspace,medicalsupplies,medical
devices,equipment,orotherpatientcareitemstoensurethatsuchuseisconsistentwiththetermsof
the applicable Arrangement(s);
e.establishingandimplementingawrittenreviewandprior
approvalprocessforallContractualArrangements,includingbutnotlimitedto,alegalreviewbycounselwithexpertiseintheAnti-KickbackStatuteandappropriatedocumentationofallinternalcontrols,thepurposeofwhichistoensurethatallexistingandneworrenewedContractualArrangementsdonotviolatetheAnti-KickbackStatute;f.establishingandimplementingawrittenreviewandapproval
processforallNon-ContractualArrangements,includingbutnotCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
12limitedto,anannuallegalreviewbycounselwithexpertiseintheAnti-KickbackStatuteandappropriatedocumentationofallinternalcontrols,thepurposeofwhichistoensurethatallNon-ContractualArangements
do not violate the Anti-Kickback Statute; g. requiring the MSD
Compliance Officer to review the
ArrangementsDatabase,internalreviewandapprovalprocess,andotherArrangementsProceduresonatleastaquarterlybasisandtoprovideareportontheresultsofsuchreviewtoMSD'sComplianceCommittee;and
h.implementingeffectiveresponseswhensuspectedviolationsoftheAnti-KickbackStatutearediscovered,includingdisclosingReportableEventspursuanttoSectionIII.(Reporting).2.NeworRenewedArrangements.Withtheexceptionof
Non-ContractualArangements, prior to entering into new Arangements
or renewing existing
Arangements,inadditiontocomplyingwiththeArangementsProceduressetforthabove,MSDshallcomplywiththefollowingrequirements(ArrangementsRequirements)
: a. Ensure that each Arangement is set forth in writing and signed
by
MSDandtheotherpartiestotheArangement;b.IncludeinthewrittenagreementarequirementthatallindividualswhomeetthedefinitionofCoveredPersonsshallcomplywithMSD'sComplianceProgram,includingthetrainingrelatedtotheAnti-Kickback
Statute. Additionally, MSD shall provide each part
totheArrangementwithacopyoftheCodeofConductandAnti-KickbackStatutePoliciesandProcedures;andc.IncludeinthewrittenagreementacertificationbythepartiestotheArrangementthatthepartiesshallnotviolatetheAnti-KickbackStatutewithrespecttotheperformanceoftheArrangement.CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 133. Records Retention and
Access. MSD shall retain and make available to
OIG,uponrequest,theArrangementsDatabaseandallsupportingdocumentationoftheArrangementssubjecttothisSectionand,totheextentavailable,allnon-privilegedcommunicationsrelatedtotheArrangementsandtheactualperformanceofthedutiesunder
the Arrangements. E.ReviewProcedures.1.GeneralDescription.
a.Engagementof IndependentReviewOrganization.Within120
daysaftertheEffectiveDate,MSDshallengageanindividualorentity(orentities),suchasanauditing,laworconsultingfirm(hereinafter"IndependentReviewOrganization"or"IRO"),toperformareviewtoassistMSDinass~ssingitscompliancewiththeobligationspursuanttoSectionIII.DofthisAgreement(Arangements
Review).
TheIROshallassess,alongwithMedtronicandMSD,whetheritcanperformtheIROreviewinaprofessionallyindependentand/orobjectivefashion,asappropriatetothenatureof
theengagement,takingintoaccountanyotherbusinessrelationshipsorotherengagementsthatmayexist.TheengagementoftheIROfortheArrangementsReviewshallnotbedeemedtocreateanattorney-clientrelationshipbetweenMedtronicorMSDandtheIRO.TheotherapplicablerequirementsrelatingtotheIRO(s)areoutlinedinAppendixBtothisAgreement,whichisincorporatedbyreference.b.Frequencyof
Arrangements Review. The Arrangements Review
shallbeperformedannuallyandshallcovereachoftheReportingPeriods.TheIRO(s)shallperformallcomponentsofeachannualArrangements
Review.
c.RetentionofRecords.TheIROandMSDshallretainandmakeavailabletoOIG,uponrequest,allworkpapers,supportingCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
14documentation,correspondence,anddraftreports(thoseexchangedbetweentheIROandMSD)relatedtothereviews.d.ResponsibilitiesandLiabilities.NothinginthisSectionIII.EaffectsMSD'sresponsibilitiesorliabilitiesunderanycriminal,civil,oradministrativelawsorregulationsapplicabletoanyFederalhealthcareprogramincluding,butnotlimitedto,theAnti-KickbackStatute.2.ArrangementsReview.TheIROshallperformareviewtoassesswhetherMSDiscomplyingwiththeArrangementsProceduresandArangementsRequirementsrequiredbySectionsIII.D.1andIII.D.2of
thisCIA.TheIROshallrandomly select a sample of75 Arrangements that
were entered into or renewed during
theReportingPeriod.TheIROshallassesswhetherMSDhasimplementedtheArangementsProceduresand,foreachselectedArrangement,theIROshallassesswhetherMSDhascompliedwiththeArrangementsProceduresandArrangementsRequirementsspecificallywithrespecttothatArrangement.TheIRO'sassessmentshallinclude,butisnotlimitedto:(a)verifyingthattheArrangementislistedintheArangementsDatabase;(b)verifyingthattheArangementwassubjecttotheinternalreviewandapprovalprocess(includingbothalegalandbusinessreview)andobtainedthenecessaryapprovalsandthatsuchreviewandapprovalisappropriatelydocumented;(
c) verifying that the remuneration related to the Arangement is
properly tracked;
(d)verifyingthattheactivitylogsareproperlycompletedandreviewed;(e)verifying(ifapplicable)thatleasedspace,medicalsupplies,medicaldevices,andequipment,andotherpatientcareitemsareproperlymonitored;(f)verifyingthattheComplianceOfficerisreviewingtheArangementsDatabase,internalreviewandapprovalprocess,andotherArangements
Procedures on a quarterly basis and reporting the results of such
review to
theComplianceCommittee;(f)verifyingthateffectiveresponsesarebeingimplementedwhenpotentialviolationsoftheAnti-KickbackStatutearediscovered;and(g)verifyingthatMSDhasmettherequirementsofSectionIII.D.2.3.ArrangementsReviewReport.TheIROshallprepareareportbasedupontheArrangementsReviewperformed(ArrangementsReviewReport).TheArrangementsReviewReportshallincludetheIRO'sfindingswithrespectto:(a)whetherMSDhasgenerallyimplementedtheArrangementsProceduresdescribedinSectionIII.D.i;and(b)specificfindingsastowhetherMSDhascompliedwiththeCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 15Arrangements Procedures
and Arrangements Requirements with respect to each of the randomly
selected Arangements reviewed by the IRO. In addition, the
Arrangements Review Report shall include observations, findings and
recommendations, if any, on possible improvements to MSD's
policies, procedures, and systems in place to ensure that all
Arrangements do not violate the Anti-Kickback Statute. 4.
Validation Review. In the event OIG has reason to believe that:
this Agreement; or (b) the IRO's findings or Arrangements Review
results are inaccurate, OIG may, at its sole discretion, conduct
its own review to determine whether the Arrangements Review
(a)MSD'sArrangementsReviewfailstoconformtotherequirementsof
complied with the requirements of the Agreement and/or the findings
or Arangements Review results are inaccurate (Validation Review).
MSD shall pay for the reasonable cost of any such review performed
by OIG or any of its designated agents. Any
ValidationReviewofReports submitted as part ofMSD's final Anual
Report must be initiated no later than one year after MSD's final
submission (as described in Section II) is received by OIG.
PriortoinitiatingaValidationReview,OIGshallnotifyMSDof its intent
to do so and provide a written explanation of why OIG believes such
a review is necessary. To resolve any concerns raised by OIG, MSD
may request a meeting with OIG to: (a) discuss the results of any
Arrangements Review submissions or findings; (b) present any
additional information to clarify the results of the Arrangements
Review or to correct the inaccuracy of the Arrangements Review;
and/or ( c) propose alternatives to the proposed Validation Review.
MSD agrees to provide any additional information as may be
requested by DIG under this Section in an expedited manner. OIG
will attempt in good faith to resolve any Arrangements Review
issues with MSD prior to conducting a Validation Review. However,
the final determination as to whether or not to proceed with a
Validation Review shall be made at the sole discretion ofOIG. 5.
Independence/Objectivity Certifcation. The IRO shall include in its
report( s) to MSD a certification or sworn affidavit that it has
evaluated its professional
independenceand/orobjectivity,asappropriatetothenatureof the
engagement, with regard to the Arrangements Review that it has
concluded that it is, in fact, independent and/or objective.
Corporate Integrity Agreement between OIG-HHS and MedtronicSofamor
Danek USA, Inc. 16 F. Disclosure Program.
MedtronicandMSDrepresentedtotheOIGthat,priortotheEffectiveDateofthisCIA,theyestablishedaDisclosureProgramthatincludesatoll-freecompliancetelephonelinetoenableindividualstodisclose,toMedtronic'sand/orMSD'sComplianceOfficerorsomeotherpersonwhoisnotinthedisclosingindividual'schainofcommand,anyidentifiedissuesorquestionsassociatedwithMedtronic'sandMSD'spolicies,conduct,practices,orprocedureswithrespecttoaFederalhealthcareprogrambelievedbytheindividualtobeapotentialviolationofcriminal,civil,oradministrativelaw.Totheextentnotalreadyaccomplished,MedtronicandMSDshallappropriatelypublicizetheexistenceofthedisclosuremechanism(~,viaperiodice-mailstoemployeesorbypostingtheinformationinprominentcommonareas).MedtronicandMSDshallcontinuetheDisclosureProgramduringtheTermoftheCIAassetforthinthisSectionIILF.TheDisclosureProgramshallemphasizeanon-retrbution,non-retaliationpolicyandincludeareportingmechanismforanonymouscommunicationsforwhichappropriateconfidentialityismaintained.UponreceiptofaDisclosure,therelevantComplianceOffcer(ordesignee)shallgatherallrelevantinformationfromthedisclosingindividuaL.TherelevantComplianceOfficer(ordesignee)shallmakeapreliminary,goodfaithinquiryintotheallegationssetforthineveryDisclosuretoensurethatheorshehasobtainedalloftheinformationnecessarytodeterminewhetherafurther
review should be conducted. For any Disclosure that is sufficiently
specific so thatitreasonably:(1)permitsadeterminationof
theappropriattnessofthe alleged
improperpracticeand(2)providesanopportnityfortakingcorrectiveaction,MedtronicorMSDshallconductaninternalreviewoftheallegationssetforthinthatDisclosureandensurethatproperfollow-upisconducted.MSD'sComplianceOfficer(ordesignee)shallmaintainaconfidentialDisclosurelog,whichincludesarecordandsummaryofeachDisclosurereceived(whetheranonymousornot)byMSD,thestatusoftherespectiveinternalreviews,andanycorrectiveactiontakeninresponsetotheinternalreviews(the"MSDDisclosureLog").Medronic'sComplianceOfficer(ordesignee)alsoshallmaintaineitherseparatelyorinconjunctionwithMSD,aconfidentialDisclosurelog,whichincludesarecordandCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
17summaryofeachDisclosurereceived(whetheranonymousornot)byMedtronic,thestatusoftherespectiveinternalreviews,andanycorrectiveactiontakeninresponsetotheinternalreviews.TheDisclosureloges)shallbeavailabletoOIG,uponrequest.WhenMedtronicandMSDprovideaccesstotheconfidentialDisclosureloges)totheOIGasspecifiedinthisSection,theyshallprovidethelogstotheOIGuponrequestandassoonaspracticable,butnotlaterthan10businessdaysfromthedateoftheOIGrequest.G.IneligiblePersons.1.Definitons.Forpurposesofthis
CIA:
a.an"IneligiblePerson"shallincludeanindividualorentitywho:i.iscurrentlyexcluded,debarred,suspended,orotherwiseineligibletoparticipateintheFederalhealthcareprogramsorinFederalprocurementornonprocurementprograms;orii.hasbeenconvictedofacriminaloffensethatfallswithintheambitof42U.S.c.1320a-7(a),buthasnotyetbeenexcluded,debared,suspended,orotherwisedeclaredineligible.b.
"Exclusion Lists" include:
i.theHHS/OIGListofExcludedIndividuals/Entities(availablethroughtheInternetathtt://oig.hhs.gov);andii.theGeneralServicesAdministration'sListof
PartiesExcludedfromFederalPrograms(availablethroughtheInternetathtt://epls.arnet.gov).c.
"Screened Persons" include all current owners (other than
shareholderswho:(1)haveanownershipinterestoflessthan5%;and(2)acquiredtheownershipinterestthroughpublictrading),allcurrentandprospectiveofficers,directors,employees,contractors,CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
18andagentsofMSDandallCoveredPersonswhoperformfunctionsrelatedtothedeliverysale,ormarketingofitemsorservicesreimbursablebyFederalhealthcareprograms.2.
Screening Requirements. Medtronic and MSD shall ensure that all
ScreenedPersonsarenotIneligiblePersons,byimplementingthefollowingscreeningrequirements.a.MedtronicandMSDshallscreenallScreenedPersonsagainsttheExclusionListspriortoengagingtheirservicesand,aspartofthehiringorcontractingprocess,shallrequiresuchpersonstodisclosewhethertheyareanIneligiblePerson.b.MedtronicandMSDshallscreenallScreenedPersonsagainsttheExclusionListswithin120daysaftertheEffectiveDateandonanannualbasisthereafter.MedtronicshallscreeninstitutionalshareholdersifMedtronichasnoticethataninstitutionalshareholderthedateofscreeningand(2)acquiredthatownershipinterestthroughpublictrading.(1)hasacquiredanownershipinterestof5%ormoreasof
c.MedtronicandMSDshallimplementapolicyrequiringallScreenedPersons(exceptprospectiveandcurrentownerswho(1)haveanownershipinterestof5%ormore;and(2)acquiredtheownershipinterestthroughpublictrading)todiscloseimmediatelyanydebarment,exclusion,suspension,orothereventthatmakesthatpersonanIneligiblePerson.NothinginthisSectionaffectstheresponsibilityof
(orliabilityfor)
MedtronicandMSDtorefrainfrombilingFederalhealthcareprogramsforitemsorservicesfurnished,ordered,orprescribedbyanIneligiblePerson.3.RemovalRequirement.IfMedtronicorMSDhasactualnoticethataScreenedPersonhasbecomeanIneligiblePerson,MedtronicorMSDshallremovesuchpersonfromresponsibilityfor,orinvolvementwith,Medtronic'sandMSD'sbusinessoperations
related to the Federal health care programs and shall remove such
person from CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
19anypositionforwhichtheperson'scompensationortheitemsorservicesfurnished,ordered,orprescribedbythepersonarepaidinwholeorpart,directlyorindirectly,byFederalhealthcareprogramsorotherwisewithFederalfundsatleastuntilsuchtimeasthepersonisreinstatedintoparticipationintheFederalhealthcareprograms.4.PendingChargesandProposedExclusions.IfMedtronicorMSDhasactualnoticethataScreenedPersonischargedwithacriminaloffensethatfallswithintheambitof42U.S.c.1320a-7(a),1320a-7(b)(1)-(3),orisproposedforexclusionduringhisorheremploymentorcontractterm,MedtronicorMSDshalltakeallappropriateactionstoensurethattheresponsibilitiesofthatpersonhavenotandshallnotadverselyaffectthequalityofcarerenderedtoanybeneficiary,patient,orresident,ortheaccuracyofanyclaimssubmittedtoanyFederalhealthcareprogram.H.NotificationofGovernmentInvestigationorLegalProceedings.Within30daysafterdiscoverybyseniormanagementatMedtronicorMSD,MedtronicorMSDshallnotifyOIG,inwriting,of
any ongoing investigation or legal
proceedingknowntoMedtronicorMSD,conductedorbroughtbyaU.S.Federal,state,or
local governental entity or agents involving an allegation that
Medtronic or MSD has .
committedacrimeorhasengagedinfraudulentactivities.Thisnotificationshallincludeadescriptionoftheallegation,theidentityoftheinvestigatingorprosecutingagency,andthestatusofsuchinvestigationorlegalproceeding.MedtronicandMSDshallalsoprovidewrittennoticetoOIGwithin30daysaftertheresolutionofthematter,andshallprovideOIGwithadescriptionof
thefindingsand/orresultsof
theinvestigationorproceedings,ifany.Totheextentnotalreadyaccomplished,within120daysaftertheEffectiveDate,MedtronicshallimplementaninternalpolicyrequiringallMedtronicemployeesimmediatelytoreporttoseniormanagementatMedtronicorMSDany~ngoinginvestigationorlegalproceeding,conductedorbroughtbyaU.S.Federal,state,orlocalgovernmentalentityoragents.CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 20i.Reporting.
1.ReportableEvents.
a.DefinitionofReportableEvent.ForpurposesofthisCIA,a"ReportableEvent"meansanythingthatinvolvesamatterbroughttotheattentionofseniormanagementatMedtronic'scorporateheadquarters,thatareasonablepersonwouldconsideraprobableviolationofcriminal,civil,oradministrativelawsapplicabletoanyFederalhealthcareprogramforwhichpenaltiesorexclusionmaybeauthorized.AReportableEventmaybetheresultofanisolatedeventoraseriesofoccurrences.b.ReportingofReportableEvents.IfMedtronicorMSDdetermines(afterareasonableopportnitytoconductanappropriaterevieworinvestigationoftheallegations)throughanymeansthatthereisaReportableEvent,MedtronicorMSDshallnotifyOIG,inwriting,within30daysaftermakingthedeterminationthattheReportableEventexists.ThereporttoOIGshallincludethefollowinginformation:i.acompletedescriptionoftheReportableEvent,includingtherelevantfacts,personsinvolved,andlegalandFederalhealthcareprogramauthoritiesimplicated;ii.adescriptionofMedtronic'sorMSD'sactionstakentocorrecttheReportableEvent;andiii.anyfurtherstepsMedtronicorMSDplanstotaketoaddresstheReportableEventandpreventitfromrecurrng.CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 21iv.NEWBUSINESSUNITS
Intheeventthat,aftertheEffectiveDate,MedtronicorMSDsells,closes,purchases,orestablishesanewbusinessunitrelatedtothedelivery,sale,marketing,orfurnishingofitemsorservicesthatmaybereimbursedbyFederalhealthcareprograms,MedtronicorMSDshallnotifyOIGofthisfactassoonaspossible,butnolaterthanwithin30daysafterthedateofsale,closure,purchase,orestablishment.Thisnotificationshallincludetheaddressofthenewbusinessunit,phonenumber,faxnumber,MedicareProvidernumber,provideridentificationnumberand/orsuppliernumber,andthecorrespondingcontractor'snameandaddressthathasissuedeachMedicarenumber.EachnewMedtronicbusinessunitshallbesubjecttoallofMedtronic'srequirementsunderthisCIA.EachnewMSDbusinessunitshallbesubjecttoallofMSD'srequirementsunderthisCIA.v.IMPLEMENTATIONANDANNUALREpORTS
A.ImplementationReport.Within150daysaftertheEffectiveDate,MedtronicandMSDshallsubmita
jointwrittenreporttoOIGsummarizingthestatusof
theirimplementationoftherequirementsofthisCIA(ImplementationReport).TheImplementation
Report shall, at a minimum, include:
1.thenames,addresses,phonenumbers,andpositiondescriptionsoftheComplianceOfficersrequiredbySectionlILA,andasummaryofothernoncompliancejobresponsibilitiestheComplianceOfficersmayhave;2.thenamesandpositionsof
themembersoftheComplianceCommitteesrequiredbySectionIII.A;3.acopyof
theapplicableCodeofConductrequiredbySectionIII.B.1;4.acopyofallPoliciesandProceduresrequiredbySectionIII.B.2;5.thenumberofindividualsrequiredtocompletetheCodeofConductcertificationrequiredbySectionIII.B.L,thepercentageofindividualswhohavecompletedsuchcertification,andanexplanationofanyexceptions(thedocumentationsupportingthisinformationshallbeavailabletoOIG,uponrequest);CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 22
6.thefollowinginformationregardingeachtyeoftrainingrequiredbySectionIII.C:a.adescriptionofsuchtraining,includingasummaryofthetopics
covered,thelengthofsessionsandascheduleoftrainingsessions;andb.thenumberofindividualsrequiredtobetrained,percentageofindividualsactuallytrained,andanexplanationofanyexceptions.AcopyofalltrainingmaterialsandthedocumentationsupportingthisinformationshallbeavailabletoOIG,uponrequest.7.adescriptionoftheArrangementsDatabaserequiredbySection
III.D.1.a;
8.adescriptionoftheinternalreviewandapprovalprocessrequiredbySectionIII.D.1.e;9.adescriptionofthetrackingandmonitoringproceduresandotherArangements
Procedures required by Section III.D.1;
10.adescriptionoftheDisclosureProgramrequiredbySectionIII.F;11.thefollowinginformationregardingtheIRO:(a)identity,address,andphonenumber;(b)acopyoftheengagementletter;(c)asurIaryanddescriptionofanyandallcurrentandpriorengagementsandagreementsbetweenMedtronicorMSDandtheIRO;and(d)theproposedstartandcompletiondatesof
the Arrangements Review;
12.acertificationfromtheIROregardingitsprofessionalindependenceand/orobjectivitywithrespecttoMedtronicandMSD;13.adescriptionoftheprocessbywhichMedtronicandMSDfulfilltherequirementsofSectionIII.GregardingIneligiblePersons;CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
2314.thename,title,andresponsibilitiesofanypersonwhoisdeterminedtobeanIneligiblePersonunderSectionIII.G;theactionstakeninresponsetthescreeningandremovalobligationssetforthinSectionIILG;andtheactionstakentoidentify,quantify,andrepayanyoverpaymentstoFederalhealthcareprogramsrelatingtoitemsorservicesfurnished,orderedorprescribedbyanIneligiblePerson;15.alistofallofMedtronic'sandMSD'slocations(includinglocationsandmailingaddresses);thecorrespondingname(s)underwhicheachlocationisdoingbusiness;thecorrespondingphonenumbersandfaxnumbers;eachlocation'sMedicareProvidernumber(s),provideridentificationnumber(s),and/orsuppliernumber(s);16.adescriptionofMedtronic's
and MSD's corporate strctures, including
identificationofanyparentandsistercompanies,subsidiaries,andtheirrespectivelinesof
business;and17.thecertificationsrequiredbySectionV.c.B.AnnualReports.MedtronicandMSDshallsubmittoOIGannuallya
jointreportwithrespecttothestatusof,andfindingsregarding,Medtronic'sandMSD'scomplianceactivitiesforeachofthefiveReportingPeriods(AnnualReport).Each
Annual Report shall include, at a minimum: 1. any change in the
identity, position description, or other noncompliance
jobresponsibilitiesoftheComplianceOfficersandanychangeinthemembershipoftheComplianceCommitteesdescribedinSectionIII.A;2.asummaryofanysignificantchangesoramendmentstothePoliciesandProceduresrequiredbySectionIII.Bandthereasonsforsuchchanges(~,changeincontractorpolicy)andcopiesofanycompliance-relatedPoliciesandProcedures;3.thenumberof
individualsrequiredtocompletetheCodeofConduct.certificationrequiredbySectionIII.B.1,thepercentageofindividualswhohavecompletedsuchcertification,andanexplanationofanyexceptions(thedocumentationsupportingthisinformationshallbeavailabletoOIG,uponrequest);CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
244.thefollowinginformationregardingeachtyeoftrainingrequiredbySectionIII.C:a.
a description of such training, including a summary of the topics
covered,thelengthofsessionsandascheduleoftrainingsessions;b. the
number of individuals required to be trained, percentage of
individualsactuallytrained,andanexplanationofanyexceptions.AcopyofalltrainingmaterialsandthedocumentationsupportingthisinformationshallbeavailabletoOIG,uponrequest.5.adescriptionofanychangestotheArangementsDatabaserequiredbySectionIII.D.1.a;6.adescriptionofanychangestotheinternalreviewandapprovalprocessrequiredbySectionIII.D.1.e;7.adescriptionofanychangestothetrackingandmonitoringproceduresandotherArrangementsProceduresrequiredbySectionIII.D.1;8.
a complete copy of all reports prepared pursuant to Section IILE,
along withacopyof
theIRO'sengagementletter(ifapplicable);9.MSD'sresponseandcorrectiveactionplanes)relatedtoanyissuesraisedbythereportspreparedpursuanttoSectionIII.E;iO.asummaryanddescriptionofanyandallcurrentandpriorengagementsandagreementsbetweenMedtronicorMSDandtheIRO,ifdifferentfromwhatwassubmittedaspartoftheImplementationReport;11.acertificationfromtheIROregardingitsprofessionalindependenceand/orobjectivitywithrespecttoMedtronicandMSD;12.asummaryofReportableEvents(asdefinedinSectionIILI)identifiedduringtheReportingPeriodandthestatusofanycorrectiveandpreventativeactionCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
25relatingtoallsuchReportableEvents;13.asummaryof
thedisclosuresintheMSDDisclosurelog(if
theMSDandMedtronicDisclosurelogsaremaintained
jointly)ortheMedtronicandMSDDisclosurelogs(iftheMSDandMedtronicDisclosurelogsaremaintainedseparately)requiredbySectionIII.Fthat:(a)relatetoFederalhealthcareprograms;(b)allegeabuseorneglectofpatients;or(c)involveallegationsofconductthatmayinvolveilegalremunerationsorinappropriatereferralsinviolationoftheAnti-KickbackStatute;14.anychangestotheprocessbywhichMedtronicorMSDfulfillstherequirementsofSectionIII.GregardingIneligiblePersons;15.thename,title,andresponsibilitiesofanypersonwhoisdeterminedtobeanIneligiblePersonunderSectionIII.G;theactionstakenbyMedtronicorMSDinresponsetothescreeningandremovalobligationssetforthinSectionIII.G;andtheactionstakentoidentify,quantify,andrepayanyoverpaymentstoFederalhealthcareprogramsrelatingtoitemsorservicesrelatingtoitemsorservicesfurnished,orderedorprescribedbyanIneligiblePerson;16.
a summary describing any ongoing investigation or legal proceeding
requiredtohavebeenreportedpursuanttoSectionIII.H.Thesummaryshallincludeadescriptionoftheallegation,theidentityoftheinvestigatingorprosecutingagency,andthestatusofsuchinvestigationorlegalproceeding;17.adescriptionofallchangestothemostrecentlyprovidedlistofMedtronic'sandMSD'slocations(includingaddresses)asrequiredbySectionV.A.15;thecorrespondingname(s)underwhicheachlocationisdoingbusiness;thecorrespondingphonenumbersandfaxnumbers;eachlocation'sMedicareProvidernumber(s),provideridentificationnumber(s),and/orsuppliernumber(s);and18.thecertificationsrequiredbySectionV.c.ThefirstAnnualReportshallbereceivedbyOIGnolaterthan60daysaftertheendofthefirstReportingPeriod.SubsequentAnnualReportsshallbereceivedbyOIGnolaterthantheanniversarydateoftheduedateofthefirstAnnualReport.CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 26C..Certifications.1. The
Implementation Report and Annual Reports shall include a
certificationbyMedtronic'sComplianceOfficerthat:a.tothebestofhisorherknowledge,exceptasotherwisedescribedintheapplicablereport,MedtronicisincompliancewithallofitsrequirementsofthisCIA;andb.
he or she has reviewed the Report as it relates to Medtronic and
has
madereasonableinquiryregardingitscontentandbelievesthattheinformationintheReportrelatingtoMedtronicisaccurateandtruthfuL.2.
The Implementation Report and Annual Reports shall include a
certificationbyMSD'sComplianceOfficerthat:a.tothebestofhisorherknowledge,exceptasotherwisedescribedintheapplicablereport,MSDisincompliancewithallofitsrequirementsofthisCIA;b.tothebestofhisorherknowledge,MSDhasimplementedproceduresreasonablydesignedtoensurethatallArangementsdonotviolatetheAnti-KickbackStatute,includingtheArrangementsProceduresrequiredinSectionIII.DoftheCIA;c.
to the best of his or her knowledge, MSD has fulfilled the
requirementsforNewandRenewedArrangementsunderSectionIII.D.2of
theCIA;andd. he or she has reviewed the Report as it relates to MSD
and has
madereasonableinquiryregardingitscontentandbelievesthattheinformationintheReportrelatingtoMSDisaccurateandtrthfuL.D.DesignationofInformation.MedtronicandMSDshallclearlyidentifyanyportionsoftheirsubmissionsthattheybelievearetradesecrets,orinformationthatiscommercialorfinancialandprivilegedorconfidential,andthereforepotentiallyexemptfromdisclosureundertheFreedomofInformationAct(FOIA),5U.S.C.552.MedtronicandMSDshallrefrainfromidentifyinganyinformationasexemptfromCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
27disclosureifthatinformationdoesnotmeetthecriteriaforexemptionfromdisclosureunderFOIA.VI.NOTIFICATIONSANDSUBMISSIONOFREpORTS
UnlessotherwisestatedinwritingaftertheEffectiveDate,allnotificationsandreportsrequiredunderthisCIAshallbesubmittedtothefollowingentities:OIG:AdministrativeandCivilRemediesBranchOfficeofCounseltotheInspectorGeneralOfficeofInspectorGeneralU.S.DepartentofHealthandHumanServices
CohenBuilding,Room5527330 Independence Avenue, S.W.
Washington,DC20201Telephone:202.619.2078
Facsimile:202.205.0604Medtronic: KathyDiGiorno ComplianceOfficer
Medtronic, Inc.
710MedtronicParkwayMinneapolis,Minnesota55432Telephone:763.505.5000
Facsimile:763.505.1000MSD:MachelleShieldsComplianceOfficerMedtronicSofamorDanek,Inc.1800PyramidPlace
Memphis,Tennessee38132Telephone:901.396.3133
Facsimile:901.344.1576CorporateIntegrityAgreementbetween
OIG-HHSandMedtronIcSofamorDanekUSA,Inc.
28Unlessotherwisespecified,allnotificationsandreportsrequiredbythisCIAmaybemadebycertifiedmail,overnightmail,handdelivery,orothermeans,providedthatthereisproofthatsuchnotificationwasreceived.Forpurposesofthisrequirement,internalfacsimileconfirmationsheetsdonotconstituteproofofreceipt
VII.OIGINSPECTION,AUDIT,ANDREVIEWRIGHTS
InadditiontoanyotherrightsOIGmayhavebystatute,regulation,orcontract,
OIGoritsdulyauthorizedrepresentative(s)mayexamineorrequestcopiesof
Medtronic'sorMSD'sbooks,records,andotherdocumentsandsupportingmaterials
and/orconducton-sitereviewsofanyof
Medtronic'sorMSD'slocationsforthepurposeof
verifyingandevaluating:(a)Medtronic'sorMSD'scompliancewiththetermsofthisCIA;and(b)Medtronic'sorMSD'scompliancewiththerequirementsofthe
Federal
healthcareprogramsinwhichtheyparticipate.ThedocumentationdescribedaboveshallbemadeavailablebyMedtronicandMSDtoOIGoritsdulyauthorizedrepresentative(s)atallreasonabletimesforinspection,audit,orreproduction.Furthermore,for
purposesofthisprovision,OIGoritsdulyauthorizedrepresentative(s)mayinterviewanyofMedtronic'sorMSD'semployees,contractors,oragentswhoconsenttobeinterviewedattheindividual'splaceof
businessduringnormalbusiness
hoursoratsuchotherplaceandtimeasmaybemutuallyagreeduponbetweenthe
individualandOIG.MedtronicandMSDshallassistOIGoritsduly
authorizedrepresentative(s)incontactingandarranginginterviewswithsuchindividualsuponOIG'srequest.Medtronic'sandMSD'semployeesmayelecttobeinterviewedwithorwithoutarepresentativeofMedtronicorMSDpresent.Medtronic'sandMSD'semployeesshallhavetherighttoberepresentedbycounselandanysuchemployeemay,athisorheroption,beaccompaniedbycounselforMedtronicorMSDand/orhisorherpersonalcounselatanyinterviewbytheOIG.Notwithstandingsucharrangement,theOIGrecognizesthatindividualshavetherighttorefusetosubmittointerviews,andMedtronicandMSDshallnotbeobligatedtorequiresuchindividualstosubmittointerviews.Ifanyindividualdecidesnottosubmittoaninterview,suchrefusalshallnotconstituteabreachofthisCIA.NeitherMedtronicnorMSDshalldiscourageemployeesfromsubmittingtointerviewsrequestedbytheOIG.CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 29
VIII.DOCUMENTANDRECORDRETENTION
MedtronicandMSDshallmaintainforinspectionalldocumentsandrecordsrelatingtoreimbursementfromtheFederalhealthcareprograms,ortocompliancewiththisCIA,forsixyears(orlongerifotherwiserequiredbylaw).ix.DISCLOSURES
ConsistentwithHHS'sFOIAprocedures,setforthin45C.F.R.Part5,OIGshallmakeareasonableefforttonotifyMedtronicorMSDpriortoanyreleasebyOIGofinformationsubmittedbyMedtronicandMSDpursuanttotheirobligationsunderthisCIAandidentifieduponsubmissionbyMedtronicandMSDastradesecrets,orinformationthatiscommercialorfinancialandprivilegedorconfidential,undertheFOIArules.Withrespecttosuchreleases,MedtronicandMSDshallhavetherightssetforthat45C.F.R.5.65(d).x.BREACHANDDEFAULTPROVISIONS
MSDisexpectedtofullyandtimelycomplywithallCIAobligationsapplicabletoMSD.MedtronicisexpectedtofullyandtimelycomplywithallCIAobligationsapplicabletoMedtronic.AbreachofthisCIAdoesnotconstituteabreachoftheSettlementAgreementbetweenMedtronic,MSD,andtheUnitedStatesexecutedcontemporaneouslyherewith.AnybreachofthetermsofthatagreementdoesnotconstituteabreachofthisCIA,excepttotheextentthatsuchabreachindependentlyalsoconstitutesabreachofthisCIA.SectionXofthisCIAspecifiesalloftheremediesavailabletotheOIGifMSDfailstosatisfyitsobligationsunderthisCIA.TheremediesavailabletotheOIGunderthisSectionXdonotpreemptorlimitanyactionthatindividualStatesmaytakeagainstMedtronicorMSDunderappropriateauthorities.A.StipulatedPenaltiesforFailuretoComplywithCertainObligations.Asacontractualremedy,Medtronic,MSDandOIGherebyagreethatfailuretocomplywithcertainobligationsassetforthinthisCIAmayleadtotheimpositionofthefollowingmonetarypenalties(hereinafterreferredtoas"StipulatedPenalties")inaccordancewiththefollowingprovisions.1.AStipulatedPenaltyof$2,500(whichshallbegintoaccrueonthedayCorporateIntegrtyAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
30afterthedatetheobligationbecamedue)foreachdayMedtronicorMSDfailstoestablishandimplementanyof
thefollowingobligationsasdescribedinSectionIII:a. a Compliance
Officer b. a Compliance Committee; c. a written Code of Conduct;
d.writtenPoliciesandProcedures;e.thetrainingofCoveredPersons;f.aDisclosureProgram;g.IneligiblePersonsscreeningandremovalrequirements;andh.NotificationofGovernmentinvestigationsorlegalproceedings.2.AStipulatedPenaltyof$2,500(whichshallbegintoaccrueonthedayafterthedatetheobligationbecamedue)foreachdayMSDfailstoestablishandimplementtheArrangementsProceduresand/orArrangementsRequirementsdescribedinSectionsIII.D.landIII.D.2
3.AStipulatedPenaltyof$2,500(whichshallbegintoaccrueonthedayafterthedatetheobligationbecamedue)foreachdayMSDfailstoengageanIRO,asrequiredinSectionIII.EandAppendixB.4.AStipulatedPenaltyof$2,500(whichshallbegintoaccrueonthedayafterthedatetheobligationbecamedue)foreachdayMedtronicandMSDfailtosubmitthejointImplementationReportorthejointAnnualReportstoOIGinaccordancewiththerequirementsofSectionVbythedeadlinesforsubmission.5.AStipulatedPenaltyof$2,500(whichshallbegintoaccrueonthedayafterthedatetheobligationbecamedue)foreachdayMSDfailstosubmittheannualArrangementsReviewReportinaccordancewiththerequirementsofSectionIII.E.CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
316.AStipulatedPenaltyof$1,500foreachdayMedtronicorMSDfailstograntaccesstotheinformationordocumentationasrequiredinSectionVII.(ThisStipulatedPenaltyshallbegintoaccrueonthedateMedtronicorMSDfailstograntaccess.)7.AStipulatedPenaltyof$5,000foreachfalsecertificationsubmittedbyoronbehalfofMedtronicorMSDaspartoftheirImplementationReport,AnnualReports,additionaldocumentationtoareport(asrequestedbytheOIG),orotherwiserequiredbythisCIA.8.
A Stipulated Penalty of $1,000 for' each day Medtronic or MSD fails
to complyfullyandadequatelywithanyobligationof
thisCIA.OIGshallprovidenoticetoMedtronicorMSD,statingthespecificgroundsforitsdeterminationthatMedtronicorMSDhavefailedtocomplyfullyandadequatelywiththeCIAobligation(s)atissueandstepsMedtronicorMSDshalltaketocomplywiththeCIA.(ThisStipulatedPenaltyshallbegintoaccrue10daysafterMedtronicorMSDreceivethisnoticefromOIGofthefailuretocomply.).AStipulatedPenaltyasdescribedinthisSubsectionshallnotbedemandedforanyviolationforwhichOIGhassoughtaStipulatedPenaltyunderSubsections
1-7 of this Section.
B.TimelyWrittenRequestsforExtensions.MedtronicandMSDmay,inadvanceoftheduedate,submitatimelywrittenrequestforanextensionoftimetoperformanyactorfileanynotificationorreportrequiredbythisCIA.NotwithstandinganyotherprovisioninthisSection,ifOIGgrantsthetimelywrittenrequestwithrespecttoanact,notification,orreport,StipulatedPenaltiesforfailuretoperformtheactorfilethenotificationorreportshallnotbegintoaccrueuntilonedayafterMedtronicfailstomeetthereviseddeadlinesetbyOIG.NotwithstandinganyotherprovisioninthisSection,ifOIGdeniessuchatimelywrittenrequest,StipulatedPenaltiesforfailuretoperformtheactorfilethenotificationorreportshallnotbegintoaccrueuntilthreebusinessdaysafterMedtronicorMSDreceivesOIG'swrittendenialofsuchrequestortheoriginalduedate,whicheverislater.A"timelywrittenrequest"isdefinedasarequestinwrtingreceivedbyOIGatleastfivebusinessdayspriortothedatebywhichanyactisduetobeperformedoranynotificationorreportisduetobefied.CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
32C.PaymentofStipulatedPenalties.1. Demand Letter. Upon a finding
that Medtronic or MSD has failed to
complywithanyoftheobligationsdescribedinSectionX.AandafterdeterminingthatStipulatedPenaltiesareappropriate,OIGshallnotifyMedtronicorMSDof:itscontractualrighttodemandpaymentoftheStipulatedPenalties(thisnotificationisreferredtoasthe"DemandLetter").SuchDemandLettershallspecificallystatetheconductthattheOIGcontendsconstitutesthebasisforimposingtheStipulatedPenalty.(a)Medtronic'sorMSD'sfailuretocomply;and(b)OIG'sexerciseof
2.ResponsetoDemandLetter.Within10daysafterthereceiptof
theDemandLetter,MedtronicorMSDshalleither:(a)curethebreachtoGIG'ssatisfactionandpaytheapplicableStipulatedPenalties;or(b)requestahearingbeforeanHHSadministrativelawjudge(ALl)todisputeOIG'sdeterminationof
noncompliance,pursuanttotheagreeduponprovisionssetforthbelowinSectionX.E.IntheeventMedtronicorMSDelectstorequestanALlhearing,theStipulatedPenaltiesshallcontinuetoaccrueuntilMedtronicorMSDcures,toOIG'ssatisfaction,theallegedbreachindispute.FailuretorespondtotheDemandLetterinoneofthesetwomannerswithintheallowedtimeperiodshallbeconsideredamaterialbreachofthisCIAandshallbegroundsforexclusionunderSectionX.D.3.Formof
Payment.PaymentoftheStipulatedPenaltiesshallbemadebycertifiedorcashier'scheck,payableto:"Secretaryof
theDepartentof Healthand
HumanServices,"andsubmittedtoOIGattheaddresssetforthinSectionVI.4.IndependencefromMaterialBreachDetermination.ExceptassetforthinSectionX.D.1.c,theseprovisionsforpaymentofStipulatedPenaltiesshallnotaffectorotherwisesetastandardforOIG'sdecisionthatMedtronicorMSDhasmateriallybreachedthisCIA,whichdecisionshallbemadeatOIG'sdiscretionandshallbegovernedbytheprovisionsinSectionX.D,below.D.ExclusionforMaterialBreachof
this CIA.
1.DefinitionofMaterialBreach.AmaterialbreachofthisCIAmeans:a.afailurebyMedtronicorMSDtoreportaReportableEvent,orCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
33takecorrectiveaction,asrequiredinSectionIII.!;b. a repeated or
flagrant violation of the obligations under this CIA,
including,butnotlimitedto,theobligationsaddressedinSectionX.A;c.afailuretorespondtoaDemandLetterconcerningthepaymentofStipulatedPenaltiesinaccordancewithSectionX.C;ord.afailuretoengageanduseanIROinaccordancewithSectionIII.E.2.NoticeofMaterialBreachandIntenttoExclude.ThepartiesagreethatamaterialbreachofthisCIAbyMedtronicconstitutesanindependentbasisforMedtronic'sexclusionfromparticipationintheFederalhealthcareprogramsandamaterialbreachofthisCIAbyMSDconstitutesanindependentbasisforMSD'sexclusionfromparticipationintheFederalhealthcareprograms.UponadeterminationbyOIGthatMedtronicorMSDhasmateriallybreachedthisCIAandthatexclusionistheappropriateremedy,OIGshallnotifyMedtronicorMSDof:(a)Medtronic'sorMSD'smaterialbreach;and(b)OIG'sintenttoexerciseitscontractualrighttoimposeexclusionMaterialBreachandIntenttoExclude").(thisnotificationishereinafterreferredtoasthe"Noticeof
3.OpportunitytoCure.MedtronicandMSDshallhave30daysfromthedateof
receiptof
theNoticeofMaterialBreachandIntenttoExcludetodemonstratetoOIG'ssatisfactionthat:a.MedtronicorMSDisincompliancewiththeobligationsoftheCIAcitedbyOIGasbeingthebasisforthematerialbreach;b.theallegedmaterialbreachhasbeencured;or
c. the alleged material breach cannot be cured within the 30-day
period,butthat:(i)MedtronicorMSDhasbeguntotakeactiontocurethematerialbreach;(ii)MedtronicorMSDispursuingsuchactionwithduediligence;and(iii)MedtronicorMSDhasprovidedCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
34toOIGareasonabletimetableforcuringthematerialbreach.4.ExclusionLetter.If,attheconclusionofthe30-dayperiod,MedtronicfailstosatisfytherequirementsofSectionX.D.3,OIGmayexcludeMedtronicfromparticipationintheFederalhealthcareprograms,andifMSDhasfailedtosatisfytherequirementsofSectionX.D.3,OIGmayexcludeMSDfromparticipationintheFederalhealthcareprograms.OIGshallnotifyMedtronicorMSDinwritingofitsdetermination.toexcludeMedtronicorMSD(thislettershallbereferredtohereinafterasthe"ExclusionLetter").SubjecttotheDisputeResolutionprovisionsinSectionX.E,below,theexclusionshall
gointoeffect30daysafterthedateof Medtronic's. or MSD's receipt of
theExclusionLetter.TheexclusionshallhavenationaleffectandshallalsoapplytoallotherFederalprocurementandnonprocurementprograms.Reinstatementtoprogramparticipationisnotautomatic.Aftertheendoftheperiodofexclusion,MedtronicorMSDmayapplyforreinstatementbysubmittingawrittenrequestforreinstatementinaccordancewiththeprovisionsat42C.F.R.1001.3001-.3004.E.DisputeResolution
1. Review Rights. Upon OIG's delivery to Medtronic or MSD of its
DemandLetterorofitsExclusionLetter,andasanagreed-uponcontractualremedyfortheresolutionofdisputesarisingunderthisCIA,MedtronicorMSDshallbeaffordedcertainreviewrightscomparabletotheonesthatareprovidedin42U.S.c.1320a-7(f)and42C.F.R.Part1005asif
theyappliedtotheStipulatedPenaltiesorexclusionsoughtpursuanttothisCIA.Specifically,OIG'sdeterminationtodemandpaymentofStipulatedPenaltiesortoseekexclusionshallbesubjecttoreviewbyanHHSALJand,intheeventof
an appeal, the HHS Departental Appeals Board (DAB), in a manner
consistent with
theprovisionsin42C.F.R.1005.2-1005.21.Notwithstandingthelanguagein42C.F.R.1005.2(c),therequestforahearinginvolvingStipulatedPenaltiesshallbemadewithin10daysafterreceiptoftheDemandLetterandtherequestforahearinginvolvingexclusionshallbemadewithin25daysafterreceiptoftheExclusionLetter.2.StipulatedPenaltiesReview.NotwithstandinganyprovisionofTitle42oftheUnitedStatesCodeorTitle42oftheCodeofFederalRegulations,theonlyissuesinaproceedingforStipulatedPenaltiesunderthisCIAshallbe:(a)whetherMedtronicorMSDwasinfullandtimelycompliancewiththeobligationsofthisCIAforwhichOIGdemandspayment;and(b)theperiodofnoncompliance.MedtronicorMSDshallCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc.
35havetheburdenofprovingitsfullandtimelycomplianceandthestepstakentocurethenoncompliance,ifany.OIGshallnothavetherighttoappealtotheDABanadverseALldecisionrelatedtoStipulatedPenalties.IftheALlagreeswithOIGwithregardtoafindingofabreachofthisCIAandordersMedtronicorMSDtopayStipulatedPenalties,suchStipulatedPenaltiesshallbecomedueandpayable20daysaftertheALlissuessuchadecisionunlessMedtronicorMSDrequestsreviewoftheALldecisionbytheDAB.IftheALldecisionisproperlyappealedtotheDABandtheDABupholdsthedeterminationofOIG,theStipulatedPenaltiesshallbecomedueandpayable20daysaftertheDABissuesitsdecision.3.ExclusionReview.Notwithstandinganyprovisionof
Title42oftheUnitedStatesCodeorTitle42of
theCodeofFederalRegulations,theonlyissuesinaproceedingforexclusionbasedonamaterialbreachofthisCIAshallbe:a.
whether Medtronic or MSD was in material breach of this CIA; b.
whether such breach was continuing on the date of the Exclusion
Letter;andc.whethertheallegedmaterialbreachcouldnothavebeencuredwithinthe30-dayperiod,butthat:(i)MedtronicorMSDhasbeguntotakeactiontocurethematerialbreachwithinthatperiod;(ii)MedtronicorMSDhaspursuedandispursuingsuchactionwithduediligence;and(iii)MedtronicorMSDprovidedtoOIGwithinthatperiodareasonabletimetableforcuringthematerialbreachandMedtronicorMSDhasfollowedthetimetable.Forpurposesoftheexclusionherein,exclusionshalltakeeffectonlyafteranALldecisionfavorabletoOIG,or,iftheALlrulesforMedtronicorMSD,onlyafteraDABdecisioninfavorofOIG.Medtronic'sorMSD'selectionofitscontractualrighttoappealtotheDABshallnotabrogateOIG'sauthoritytoexcludeMedtronicorMSDupontheissuanceof
anALl'sdecisioninfavorofOIG.If
theALlsustainsthedeterminationofOIGanddeterminesthatexclusionisauthorized,suchexclusionshalltakeeffect20daysaftertheALlissuessuchadecision,notwithstandingthatMedtronicorMSDmayrequestreviewof
theALldecisionbytheDAB.Ifthe DAB finds in favor ofOIG after
anALldecisionadversetoOIG,theexclusionshalltakeeffect20daysaftertheDABCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 36
decision.MedtronicorMSDshallwaiveitsrighttoanynoticeofsuchanexclusionifadecisionupholdingtheexclusionisrenderedbytheALlorDAB.IftheDABfindsinMedtronicorMSD,MedtronicorMSDshallbereinstatedeffectiveonthedate
favorofof the onginal exclusion.
4.FinalityofDecision.ThereviewbyanALlorDABprovidedforaboveshallnotbeconsideredtobeanappealrightansingunderanystatutesorregulations.Consequently,thepartestothisCIAagreethattheDAB'sdecision(ortheALl'sdecisionifnotappealed)shallbeconsideredfinalforallpurposesunderthisCIA.XI.EFFECTIVEANDBINDINGAGREEMENT
ConsistentwiththeprovisionsintheSettlementAgreementpursuanttowhichthisCIAisentered,andintowhichthisCIAisincorporated,Medtronic,MSDandOIGagreeasfollows:A.ThisCIAshallbebindingonthesuccessors,assigns,andtransfereesofMedtronicandMSD;B.ThisCIAshallbecomefinalandbindingonthedatethatMedtronicorMSDbecomesobligatedtomakepaymenttotheUnitedStatesoftheSettlementAmountfromtheEscrowAccountestablishedpursuanttotheSettlementAgreementbetweentheUnitedStates,Medtronic,andMSD,signedonor
aboutthedateofsignatureof this CIA.
MedtronicandMSDshallnotifytheOIGofthedatethatMedtronicorMSDbecomesobligated
to make payment of that Settlement Amount;
C.AnymodificationstothisCIAshallbemadewiththepriorwrittenconsentofthepartiestothisCIA;D.OIGmayagreetoasuspensionofMedtronc'sorMSD'sobligationsunderthethedelivery,sale,marketing,or
CIAintheeventof Medtronic'sorMSD'scessationof
furnishingofitemsorservicesreimbursedbyanyFederalhealthcareprograms.IfsuchcessationoccursandMedtronicorMSDisrelievedofitsCIAobligationsbyOIG,MedtronicorMSDshallnotifyOIGatleast30daysinadvanceofthedateonwhichMedtronicorMSDintendstobegindelivering,selling,marketing,orfurnishingitemsorservicesreimbursedbyanyFederalhealthcareprograms.UponreceiptofsuchCorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 37
notification,OIGshallevaluatewhethertheCIAshouldbereactivatedormodified.E.TheundersignedMedtronicandMSDsignatoriesrepresentandwarrantthattheyareauthorizedtoexecutethisCIA.TheundersignedOIGsignatoryrepresentsthatheissigningthisCIAinhisofficialcapacityandthatheisauthorizedtoexecutethisGA..
CorporateIntegrityAgreementbetween
OIG-HHSandMedtronicSofamorDanekUSA,Inc. 38ON BEHALF OF MEDTRONIC,
INC.KATHEEN ERr KSON DiGrORNOCompliance 0 . cerMTY COBB,Hogan &
H sonCounsel for Medtronic, Inc.7-/ l- - bDATE-:lI" / O~DATE:ii
lOl/ DAON BEHAF OF MEDTRONIC SOFAMOR DANK USA, INc.PETER
WEHRYPresidentMedtronic Sofamor Danek USA, Inc.TODD N. SHELDON,
ESQ.Vice President and Senior Legal CounselMedtronic Sofamor Danek
USA, Inc.Corporate Integnty Agreement betweenOIG-HHS and Medtronic
Sofamor Danek USA, Inc.39DATEDATE/Janice M. Symchych/ /Kathleen
Erickson DiGiorno/ /Ty Cobb/ ON BElMLF pF MEDTRONlC, INC.,JANICE M.
SYMCHYCH~ ESQ. iVice Predent and Deputy Geeral CounslMooiionic,
Inc. ;DATEKATHLEE .RCKSON DiGIORNOCompliance OffcerMedc, Inc,DATETY
CO~B, ESQ.. Hogan & HaiionCounsel for MedtrJU, IDC.DATE PElER
WEHRYPresfdmtMedtrnle Sofimor Panek USA. Inc.ON BEJl' 0" MEDl'Jl9fC
SOF'AMR. DANK USA. INC.!all/1/DATETODl) N. SHElDON, ESQ,Vice
PJcsidon and Senior L~ CounselMednonic Sofamor Dank USA,
Inc.DATECOIJ~lle Intry A8~~nOllj-1lHS iiid Medttlo Soromor ODidc
V9A, In."39/Peter Wehrly/ ON BEHAF OF MEDTRONIC, INC.-JANICE M.
SYMCHYCH, ESQ.Vice President and Deputy General CounselMedtronic,
Inc.DATEKATHLEEN ERICKSON DiGIORNOCompliance OfficerMedtronic,
Inc.DATETY COBB, ESQ.Hogan & HarsonCounsel for Medtronic,
Inc.DATEON BEHAF OF MEDTRONIC SOFAMOR DANK USA, INc.PETER
WEHRLYPresidentMedtronic Sofamor Danek USA, Inc.DATE TODD N. .SHEL
/ N, ESQ.Vice President and Senior Legal CounselMedtronic Sofamor
Danek USA, Inc.7/ N/OIJDATECorporate Integrty Agreement
betweenOIG-HHS and Medtronic Sofamor Danek USA, Inc.39/Todd N.
Sheldon/ ifCO B, ESQ.Hogan HarsonCounsel or Medtronic Sofamor Danek
USA, Inc.7 'l /t&DATE /~11 fJDATE ION BEHALF OF THE OFFICE OF
INSPECTOR GENERAOF THE DEPARTMENT OF HEALTH AND HUMA
SERVICESGREGORY E. DEMSKEAssistant Inspector General for Legal
AffairsOffce of Inspector GeneralOffce of Counsel to the Inspector
GeneralU. S. Deparent ofHealth and Hwnan ServicesCorporate
Integrity Agreement betweenOIG-HHS and Medtronic Sofamor Danek USA,
Inc.40DATE/Machelle Shields/ /Ty Cobb/ MACHELLE SHIELDSCompliance
OfficerMedtronic Sofamor Danek USA, Inc.DATETY COBB, ESQ.Hogan
& HartsonCounsel for Medtronic Sofamor Danek USA, Inc.DATEON
BEHALF OF THE OFFICE OF INSPECTOR GENERALOF THE DEPARTMENT OF
HEALTH AND HUMA SERVICES7 /7 /ai,GREGORY E. DEMSKEAssistant
Inspector General for Legal AffairsOffice of Inspector
GeneralOffice of Counsel to the Inspector GeneralU. S. Deparment
ofHealth and Human ServicesDATECorporate Integrity Agreement
betweenOIG-HHS and Medtronic Sofamor Danek USA, Inc.40/Gregory E.
Demske/ APPENDIX A ARRGEMENTSDATABASE
MSDshallcreateandmaintainanArrangementsDatabasetotrackallnewandexistingArrangements,includingContractualArangementsandNon-ContractualArrangements,inordertoensurethateachArrangementdoesnotviolatetheAnti-KickbackStatute.A.TheArrangementsDatabaseshallcontaincertaininformationtoassistMSDin
evaluatingwhethereachContractualArrangementviolatestheAnti-KickbackStatute,
including but not limited to the following:
1.EachpartyinvolvedintheArrangement;
2.ThetypeofArangement(~,physicianemploymentcontract,medical
directorship,leaseagreement);3.Thetermof the
Arrangement,includingtheeffectiveandexpirationdatesandanyautomaticrenewalprovisions;4.TheamountofcompensationtobepaidpursuanttotheArrangementand
themeansbywhichcompensationispaid;5.Themethodologyfordeterminingthecompensationunderthe
Arangements,includingthemethodologyusedtodetenninethefairmarketvalueofsuchcompensation;6.Whethertheamountofcompensationtobepaidpursuanttothe
Arrangementisdetenninedbasedonthevolumeorvalueofreferralsbetweentheparties;7.
Whether each party has fulfilled the requirements of Section
III.D.2; and
8.WhethertheArrangementsatisfiestherequirementsofanAnti-Kickback
Statute safe harbor.
B.TheArrangementsDatabaseshallcontaincertaininfonnationtoassistMSDinevaluatingwhethereachNon-ContractualArangementviolatestheAnti-KickbackStatute,includingbutnotlimitedtothefollowing:1.Thenameof
the entity or individl1al receiving the Non-Contractual
remuneration;2.ThetypeofNon-Contractualrerimneration(listingintheaggregatemultipledistrbutionsof
thesametypeof Non-Contractualremunerationtoeachentity or
individual); 3.Theaggregatevalueofeachtypeof
Non-Contractualremunerationgiven
toeachentityorindividualduringtheReportingPerioCl;
4.WhethertheNon-ContractualremunerationgivenpursuanttotheNon-
ContractualArrangementisdeterminedbasedonthevolumeorvalueofreferralsbetweentheparties;and5.WhethertheNon-ContractualArrangementsatisfiestherequirementsof
anAnti-KickbackStatutesafeharbor.2 APPENDIXB INDEPENDENT REVIEW
ORGANIZATION This Appendix contains the requirements relating to
the Independent Review Organization (IRO) required by Section III.E
ofthe CIA. A.IROEngagement. MSD shall engage an IRO that possesses
the qualifications set forth in Paragraph B, below, to perform the
responsibilities in Paragraph C, below. The IRO shall conduct the
review in a professionally independent and/or objective fashion, as
set forth in
ParagraphD.Within30daysafterOIGreceiveswrittennoticeofthe identity
ofthe sele.ctedIRO,OIGwillnotifyMSDif the IRO is unacceptable.
Absent notification from OIG that the IRO is unacceptable, MSD may
continue to engage the IRO. IfMSDengagesanewIROduringthetermof the
CIA, this IRO shall also meet the requirements of this Appendix. If
a new IRO is engaged, MSD shall submit the information identified
in Section V.A. i i to OIG within 30 days of engagement ofthe
IRO.Within30daysafterOIGreceiveswrittennoticeoftheidentityof the
selected IRO,OIGwilnotifyMSDif the IRO is unacceptable. Absent
notification from OIG that the IRO is unacceptable, MSD may
continue to engage the IRO. B.IROQualifications. The IRO shall: 1.
assign individuals qualified to conduct the Arangements Review; and
2. have sufficient staff and resources to conduct the reviews
required by the CIA on a timely basis. C. IRO Responsibilities. The
IRO shall: 1. perform each Arrangements Review in accordance with
the specific requirements of the CIA; 2. respond to all OIG
inquires in a prompt, objective, and factual manner; and . 3.
prepare timely, clear, well-written reports that include all the
information required by Section III.E.3 of the CIA.
D.IROIndependence/Obiectivity.
TheIROmustperformtheArrangementsReviewinaprofessionallyindependentand/orobjectivefashion,asappropriatetothenatureof
theengagement,takingintoaccountanyotherbusinessrelationshipsorengagementsthatmayexistbetweentheIROandMSDand/orMedtronic.E.IRORemoval/Termination.
1.Provider.IfMSDterminatesitsIROduringthecourseof
theengagement,MSDmustsubmitanoticeexplainingitsreasonstoOIGnolaterthan30daysaftertermination.MSDmustengageanewIROinaccordancewithParagraphAofthis'Appendix.2.DIGRemovalofIRO.IntheeventOIGhasreasontobelievethattheIROdoesnotpossessthequalificationsdescribedinParagraphB,isnotindependentand/orobjectiveassetforthin:ParagraphD,orhasfailedtocarryoutitsresponsibilitiesasdescribedinParagraphC,OIGmay,atitssolediscretion,requireMSDtoengageanewIROinaccordancewithParagraphAofthisAppendix.PriortorequiringMSDtoengageanewIRO,OIGshallnotifyMSDofitsintenttodosoandprovideawrittenexplanationofwhyOIGbelievessuchastepisnecessary.ToresolveanyconcernsraisedbyOIG,MSDmayrequestameetingwithOIGtodiscussanyaspectoftheIRO'squalifications,independenceorperformanceofitsresponsibilitiesandtopresentadditionalinformationregardingthesematters.MSDshallprovideanyadditionalinformationasmayberequestedbyOIGunderthisParagraphinanexpeditedmanner.OIGwilattemptingoodfaithtoresolveanydifferencesregardingtheIROwithMSDpriortorequiringMSDtoterminatetheIRO.However,thefinaldetennnationastowhetherornottorequireMSDtoengageanewIROshallbemadeatthesolediscretionofOIG.2
